FDA Grants PMA Approval For Hologic's Aptima HIV-1 Quant Assay

(RTTNews) - Hologic Inc. (HOLX) said that the U.S. Food and Drug Administration has granted PMA approval for the Company's HIV-1 viral load monitoring assay. The Aptima HIV-1 Quant assay is a nucleic acid amplification test for the quantitative detection of RNA from HIV in plasma specimens.

The Aptima HIV-1 Quant assay runs on Hologic's Panther system, a market-leading, integrated platform that fully automates all aspects of testing, from sample to result. The system substantially reduces hands-on time for laboratories by providing random and continuous access with rapid turnaround time.

A number of published studies have compared the performance of the Aptima HIV-1 Quant assay with other HIV viral load monitoring assays currently on the market. The results of these studies demonstrate that the Aptima HIV-1 Quant assay provides repeatable, reliable results for consistent quantitation.

This consistency is critical for patient management, as it ensures that detected changes in viral load are due to potential clinical changes rather than assay variation.

The Hologic Aptima HIV-1 Quant assay uses a dual target approach against highly conserved regions in the HIV genome and is designed to deliver reliable, consistent quantitation across HIV-1 groups and subtypes. Availability of the assay on the Panther system enables every step, from sample to result, to be completed within a single integrated instrument.

This combination of performance and automation will provide labs the ability to become even more efficient while meeting today's demands for HIV treatment monitoring.